Article Archive

A strong CMC strategy is crucial for biotech startups moving into clinical trials. Regulatory agencies expect detailed documentation to confirm a drug’s safety, consistency, and quality, which means early planning can prevent costly delays. Startups that take a proactive approach…

The pharmaceutical landscape has evolved dramatically since the first synthetic drugs were developed over a century ago, highlighting the ongoing debate of biologics and small molecules. Today, healthcare providers can choose between traditional small-molecule drugs and sophisticated biological therapies, each…

The biopharmaceutical landscape demands increasingly sophisticated approaches to drug development and commercialization. Modern regulatory strategy has emerged as a powerful catalyst for innovation, enabling companies to navigate complex regulatory requirements while accelerating the delivery of breakthrough therapies to patients. From…

In today’s complex biopharmaceutical landscape, the path from discovery to market approval demands increasingly sophisticated regulatory strategies. Early-stage regulatory planning has emerged as a critical success factor, directly impacting development timelines, costs, and approval probabilities while helping organizations navigate evolving…

The submission of an IND or other global first-in-human regulatory filing represents a pivotal milestone in transforming scientific discoveries, known as new chemical entities, into potential medical breakthroughs. This process involves a comprehensive evaluation of drug candidates to ensure their…

What is process control? Process control is the backbone of precision in manufacturing, providing the framework needed to maintain quality, safety, and efficiency. In the biopharmaceutical industry, even minor deviations can have significant consequences; process control plays a vital role…